FDA Authorizes Marketing of first Nicotine Pouches – A Breakthrough for Harm Reduction and Smoking Cessation Harm reduction

The U.S. Food and Drug Administration (FDA) has authorized the marketing of 20 ZYN nicotine pouches after a rigorous scientific review. These products meet the public health standard established by the 2009 Family Smoking Prevention and Tobacco Control Act, which evaluates overall risks and benefits.

“This is a significant step for harm reduction and great news for all remaining smokers, as it ensures there will be opportunities to quit smoking even in the future,” said Markus Lindblad, Communications Director at Pouch Patrol.

Pouches benefits switchers according to the F.D.A.

The FDA found that these products contain “substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco”, thereby lowering the risks of cancer and serious illnesses.

Matthew Farrelly, Ph.D., from the FDA’s Center for Tobacco Products, noted:

“The data show that these nicotine pouch products meet the bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

EU should learn from the U.S

Europe has long recognized the benefits of nicotine alternatives, as evidenced by snus in Sweden and studies conducted by Germany’s BfR. The FDA’s decision reinforces these findings, urging EU policymakers to adopt evidence-based regulations.

“The EU institutions, national health authorities, and politicians must take note of the FDA’s important stance. The EU must also focus on science rather than misleading arguments against attractive nicotine alternatives from state-funded lobby organizations,” added Lindblad.

More and faster approvals for nicotine pouches

Analysts have hailed the FDA’s decision as groundbreaking, predicting faster approvals for other nicotine pouch manufacturers.

“This marks a new era for the industry,” said Lindblad. “The EU should align its Tobacco Products Directive with such advancements to ensure smokers have access to effective alternatives.”

More information:

FDA-approved ZYN products (3 mg and 6 mg):

• ZYN Chill
• ZYN Cinnamon
• ZYN Citrus
• ZYN Coffee
• ZYN Cool Mint
• ZYN Menthol
• ZYN Peppermint
• ZYN Smooth
• ZYN Spearmint
• ZYN Wintergreen

Please visit the FDA’s Searchable Tobacco Products Database for more details.